Trials / Completed
CompletedNCT02964208
AMPLATZER™ LAA Occluder Post Approval Study (PAS)
AMPLATZER™ LAA Occluder Post Approval Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 520 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this multicenter, non-randomized observational post-approval is to compile real world outcome data on the use of an AMPLATZER LAA Occluder in subjects with non-valvular atrial fibrillation (NVAF). The AMPLATZER LAA Occluders is a transcatheter, self-expanding nitinol device intended for use in preventing thrombus embolization from the LAA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AMPLATZER™ LAA Occluder | The AMPLATZER™ LAA Occluder is intended to prevent thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular Atrial Fibrillation (AF). It may be considered for use in patients who have a high risk of stroke and bleeding and are deemed by their physician to have an appropriate rationale to seek a non-pharmacologic alternative to long term anticoagulants. |
Timeline
- Start date
- 2016-12-08
- Primary completion
- 2022-06-13
- Completion
- 2022-08-10
- First posted
- 2016-11-16
- Last updated
- 2024-03-29
- Results posted
- 2024-03-29
Locations
22 sites across 7 countries: Argentina, Belgium, Canada, Chile, Germany, Italy, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02964208. Inclusion in this directory is not an endorsement.